Abuse liability is an important determinant of whether a nicotine pouch product is Appropriate for the Protection of the Public Health.
Abuse liability studies assess nicotine pharmacokinetics, subjective effects, and use behaviors under both controlled and ad libitum conditions, with final determinations based on the totality of evidence.
Labeled nicotine strength is often used as a simple proxy for abuse liability, but product chemistry, nicotine form, pH, release kinetics, matrix composition, and use behavior may substantially modify the relationship between labeled content and actual nicotine exposure.
Purpose: To determine whether nominal nicotine content is reliable predictor of abuse liability.
